Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-17 @ 4:19 PM
Study NCT ID:
NCT03695432
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2018-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 910}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-03', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with anti HI titer >=1:40', 'timeFrame': '6 months', 'description': 'Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly'}, {'measure': 'Percentage subjects with increasing antibody titer >=4 times', 'timeFrame': '6 months', 'description': 'Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly'}]}, 'conditionsModule': {'keywords': ['Influenza', 'Vaccine', 'Probiotic', 'Influenza-like Illness'], 'conditions': ['Influenza-like Illness']}, 'referencesModule': {'references': [{'pmid': '34914726', 'type': 'DERIVED', 'citation': 'Koesnoe S, Masjkuri N, Adisasmita A, Djauzi S, Kartasasmita C, Sundoro J, Nadjib M, Korib M, Muthia AN, Muzellina VN, Habibah U, Nursyirwan SA, Djaya KH, Bachtiar NS, Sari RM. A randomized controlled trial to evaluate the effect of influenza vaccination and probiotic supplementation on immune response and incidence of influenza-like illness in an elderly population in Indonesia. PLoS One. 2021 Dec 16;16(12):e0250234. doi: 10.1371/journal.pone.0250234. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'To asses the effect of the probiotic and influenza vaccination alone and combination on enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the elderly', 'detailedDescription': 'To see percetange of subjects seroconvertion and seroprotection before and after intervention in the elderly (\\>60 years), and monitored for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all health elderly aged ≥ 60 years\n* who came to the vaccination and health education activities in the entire East Jakarta District Health Center\n* with Body Mass Index (BMI) 17,5-29,9\n* healthy mental status (MMSE score of 28-30)\n\nExclusion Criteria:\n\n* subject who have contraindications to influenza vaccinations\n* are undergoing treatment related to immune system modulation in the past 4 weeks\n* therapy for immunossuppresants and/ or corticosteroids eqivalent to prednisone ≥ 20 mg/day that is being lived more than 2 weeks or has only been stopped less than 3 months before the study\n* recieved influenza vaccination less than one year before\n* Currently consuming probiotic agents, either in the form of a manufacturer or natural for more than 7 days.'}, 'identificationModule': {'nctId': 'NCT03695432', 'briefTitle': 'Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly', 'orgStudyIdInfo': {'id': 'Vaccine2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine', 'description': 'Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly', 'interventionNames': ['Biological: Flubio']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic', 'interventionNames': ['Dietary Supplement: Lacidofil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Vaccine', 'description': 'Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly', 'interventionNames': ['Other: Placebo Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo probiotic', 'description': 'capsul', 'interventionNames': ['Other: Placebo probiotic']}], 'interventions': [{'name': 'Flubio', 'type': 'BIOLOGICAL', 'description': 'Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly', 'armGroupLabels': ['Vaccine']}, {'name': 'Lacidofil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic The antibiotic will be given 2 times each day for 6 months', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo Vaccine', 'type': 'OTHER', 'description': 'Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly', 'armGroupLabels': ['Placebo Vaccine']}, {'name': 'Placebo probiotic', 'type': 'OTHER', 'description': 'Capsul', 'armGroupLabels': ['Placebo probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13310', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Integrated Health Post, at Pulo Gadung District', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Sukamto Koesnoe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sukamto Koesnoe', 'investigatorAffiliation': 'Indonesia University'}}}}